18F-FDG PET/CT Imaging for Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer Female, Breast Cancer Recurrent

In brief

Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC. Objectives Primary: To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment. Secondary: * Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT. * Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome. * Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome. * Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome. * Blood and tumor samples for molecular characterisation:

Key facts

Study ID

NCT05730608

Run by

Vestre Viken Hospital Trust

People needed

300

Starts

2023-02-16

Expected to finish

2032-12-31

Last updated by the study team

2024-05-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with high risk primary or recurrent breast cancer
• Non pregnant women > 18 years
• Not receiving active treatment of other cancer types.
• Eastern Cooperative Oncology Group (ECOG) status 0-2.

You may not qualify if…

• Pregnant woman
• Males
• Age under 18
• Patients receiving active treatment for other cancers
• Poor general conditipon (ECOG 3 or higher)

Where it is running

• Drammen Hospital - Vestre Viken HF — Drammen, Norway (enrolling)

Full record on ClinicalTrials.gov

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